Role of IV Estrogen in trauma hemorrhagic shock patients
- Conditions
- Health Condition 1: null- Trauma Hemorrhagic Shock
- Registration Number
- CTRI/2013/12/004181
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 40
•Trauma victims
•Systolic Blood pressure (SBP) of <=90mmHg.
•Estimated time to study drug administration <8hrs post trauma
•Glasgow coma scale (GCS) score of between 3 and 8 prior to intubations and/or sedation, due to difficulty of patients cooperation in assessment after these intervention
•Age: Less than 18 years
•Known incarcerated individual
•Cardiopulmonary resuscitation (CPR) prior to study drug administration
•Known contraindication for estrogen (male sex is NOT a contraindication)
•Patients already resuscitated with colloids or crystalloids before reporting to the emergency department.
•Pregnant lady
•Non hemorrhagic-shock:
1- Tension pnumothorax
2- Septic
3- Neurogenic
•Previous history of thrombosis events such as DVT (Deep venous thrombosis)
•Injury time unknown
•Drug Medication:
1.Intravenous drug abuse
2.oral contraceptive
3.Estrogen
4.Heparin induced thrombocytopenia
•Stroke
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Efficacy of intravenous estrogen in terms of survival or death. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 0 day,3 day, 7th day,14th day <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢To analysis the effect of estrogen on immunological alternation and its correlation with survival or death. <br/ ><br> <br/ ><br>2.Time frame: 1,3, 7, and 14 days <br/ ><br> <br/ ><br>â?¢To study the role of estrogen on development of sepsis with or without muliorgan failure (MOF) on days 1, 3, 7, and 14. <br/ ><br> <br/ ><br>â?¢Survival or death on days 30 and 1 year of follow-up. <br/ ><br> <br/ ><br>â?¢To observe the adverse effect of estrogen: <br/ ><br>1.Minor events <br/ ><br>2.Major events <br/ ><br>3.Other thrombosis events <br/ ><br>Timepoint: Time frame: 1,3, 7, and 14 days